UMIN-CTR Clinical Trial

Public title

A confirmatory study examining effects of continuous intake of test food on healthy adults

Acronym

A confirmatory study examining effects of continuous intake of test food on healthy adults

Scientific Title

A confirmatory study examining effects of continuous intake of test food on healthy adults

Scientific Title:Acronym

A confirmatory study examining effects of continuous intake of test food on healthy adults

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine effects on muscle mass, bone density, cognitive function, body composition, and QOL in postmenopausal women aged 50 to 69 after 24 weeks of continuous intake of test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

muscle mass, bone density

Key secondary outcomes

Markers in blood (osteocalcin, TRACP-5b, BDNF, FSH, LH, estrone, HDL-C, LDL-C, TC, and TG) and urine (deoxypyridinoline), scores of Cognitrax, vital signs, QOL questionnaire (SF-36, bowel habit questionnaire)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 4 capsules of test food t.i.d.

Interventions/Control_2

Take 4 capsules of placebo t.i.d.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Female

Key inclusion criteria

1.Age:50 to 69 years old
2.Gender:Women
3.Healthy adults (We define "healthy adults" as those who currently have neither severe organ damage nor a particular disease, who currently do not receive treatment associated with those disorders, and who currently do not receive any kind of drug treatment. We judge whether or not a candidate meets this definition according to the self-report submitted when a clinical trial is commenced)
4.Postmenopausal women
5.Those who can give their written informed consent

Key exclusion criteria

1.Those who currently receive continuous drug treatment (except for drugs that are taken as needed)
2.Those who currently undergo dietary or exercise therapy under the direction of physicians
3.Those with a past medical history of any of the following: hepatic disease, severe disorder (kidney, endocrine, cardiovascular, gastrointestinal, and lung diseases, and blood and metabolic disorders), or complications
4.Those with a past medical history of mental disorder (such as depression)
5.Those with a past and current medical history of drug or food allergy
6.Those who work night shifts or irregular shifts
7.Those who currently take health food and supplements (except for those who can stop taking them after they have signed an informed consent form)
8.Smokers
9.Those who currently take warfarin product (such as Warfarin, Warlin, Arefarin, Warfarin K, etc.)
10.Those who have metallic orthopedic implants
11.Those who underwent barium enema in 3 days before the commencement of this clinical trial
12.Those who have done fingernail or toenail designs on the day of a bone density test
13.Those who are participating in other clinical trials or participated in the past 1 month and then took their test products
14.Any other conditions, in the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial

Target sample size

66

Name of lead principal investigator

1st name
Middle name
Last name	Kiyoshi Nakamura

Organization

Higashi Koganei Sakura Clinic

Division name

Chairman

Zip code

Address

4-37-26,Higashicho,Koganei-shi,Tokyo,Japan

TEL

042-382-3081

Email

higashikoganeisakura-clinic@imeq.co.jp

Name of contact person

1st name
Middle name
Last name	Naomi Yuzawa

Organization

imeQ co.Ltd

Division name

Sales department

Zip code

Address

2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan

TEL

03-6225-6222

Homepage URL

Email

n-yuzawa@imeq.co.jp

Institute

imeQ co.Ltd

Institute

Department

Personal name

Organization

euglena Co.Ltd

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

14

Day

Date of IRB

Anticipated trial start date

2018

Year

04

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

26

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036429